510(k) · Cleared
ClearedMOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterngold Dental, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Sep 28, 2017 as substantially equivalent to K153099 (Prismatik Dentalcraft, Inc., 2016) and 2 other predicates after a 108-day review. Its family tree reaches back 11 generations to 1996. 2 later devices descend from it.
- Decided
- Sep 28, 2017
- Review
- 108 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K960026 (1996). 91 ancestors in all, the oldest K874590 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- This deviceK171728 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC · 2017
- Descendant · cites it directly · 1 of its ownK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022
- Descendant · 2 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- This deviceK171728 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −1 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| 0 (this device) | K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | Sterngold Dental, LLC | 2017 | — |
| +1 | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | 2022 | — |
| +2 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 12 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153099 | Inclusive Tapered Implant SystemSummary page 4…Endosseous dental implant Classification: Class II 3. Predicate Devices: Primary Predicates Prismatik Inclusive Tapered implant - K153099 IMTEC MDI MII One-Piece Implant 2.9mm - K081653 Reference Predicates Sterngold PUR Implant System - K151928… | 2016 |
| * | K081653 | Mdi Mii One-Piece Implant, 2.9MMSummary page 4…Class II 3. Predicate Devices: Primary Predicates Prismatik Inclusive Tapered implant - K153099 IMTEC MDI MII One-Piece Implant 2.9mm - K081653 Reference Predicates Sterngold PUR Implant System - K151928 Implant Direct Spectra System Dental Implants 2008 -… | 2008 |
| * | K090234 | Spectra System Dental Implants 2008Summary page 4…DI MII One-Piece Implant 2.9mm - K081653 Reference Predicates Sterngold PUR Implant System - K151928 Implant Direct Spectra System Dental Implants 2008 - K090234 Sterngold MOR 2.1mm and 2.4mm - K153173 4. Product Description: PUR 3.2mm Implant System The PUR 3.2mm Implant… | 2009 |
| † | K151928 | PUR Dental Implant System | 2015 |
| † | K153173 | MOR Implant System | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213576 | Tatum Surgical Dental Implant System | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 12 of the 91 ancestors have a recall of any class.
- Of its descendants, K213576 (Suncoast Dental, Inc. Dba Tatum Surgical, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The MOR™ implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.…
Read the full statement (188 words)
The MOR™ implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The MOR™ implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.
The PUR Implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The PUR implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171728: MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171728
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026